MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 102; GENERATOR

Model Number 102

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Anxiety (2328); Cognitive Changes (2551)

Event Date 09/23/2019

Event Type  Injury  

Event Description

It was reported that the patient's generator battery was getting low, although it is still functioning.The patient has been experiencing anxiety and memory loss, which the patient believes is due to the low battery.The physician stated that this may be due to the patient's electroconvulsive therapy, but he is unsure of the relationship to the vns.No additional relevant information has been received to date.No known surgical intervention has occurred to date.

Event Description

The patient underwent generator replacement due to battery depletion.The explant facility is known to not return explanted devices.The suspect device has not been received to date.No additional relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 102
• Type of Device: GENERATOR
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 9857015
• MDR Text Key: 184173732
• Report Number: 1644487-2020-00470
• Device Sequence Number: 1
• Product Code: MUZ
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 07/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/25/2007
• Device Model Number: 102
• Device Lot Number: 014188
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 02/25/2020
• Initial Date FDA Received: 03/19/2020
• Supplement Dates Manufacturer Received: 06/10/2020
• Supplement Dates FDA Received: 07/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR